SML partnered with Unicycive to provide end-to-end CDMO services right from development & supply of APIs to finished dosage form.

Unicycive is expected to file the New Drug Application for OLC by mid-2024 with potential approval by mid-2025.

Based on the outcome of the pivotal clinical studies, Unicycive has entered into long term manufacturing and supply agreement with SML and agreed to place a binding purchase order for supply of OLC tablets by June 30, 2025. Additionally, Unicycive has agreed to place orders for additional tablets to be delivered between December 31, 2025, and June 30, 2026.

Apart from the supply arrangement, SML is expected to receive $10 million as milestone income spanning over filing, approval and launch of the product. Additionally, in anticipation of increased product demand Unicycive will also fund the establishment of new manufacturing block at Shilpa’s site.

Raichur-based Shilpa Medicare is a vertically integrated, manufacturer and distributor of quality drugs to global markets; specializing in the oncology therapeutic segment and introducing novel drugs focusing on patient convenience and compliance.

The company reported a consolidated net profit of Rs 24.50 crore in Q4 FY24 as against a net loss of Rs 8.04 crore posted in Q4 FY23. Revenue grew by 10.7% year on year to Rs 219.69 crore during the quarter.